Medical device approval process in China since the introduction of the China Food and Drug Administration

Abstract

China's medical device market is continuously growing since the last decade and increasingly attractive for foreign medical device manufacturers. However, marketing products in China as a foreign manufacturer is challenging due to the rapidly changing regulatory environment and lack of available information and documents published in English. This work addresses the recent introduction of the China Food and Drug Administration (CFDA) and presents the current CFDA approval processes and required documentation based on research of the original documents of the CFDA in Chinese language.